El estudio QUADRA-PE evaluará la seguridad y eficacia del sistema de trombectomía Katana™
Akura Medical, a Shifamed portfolio company focused on reshaping the landscape of venous thromboembolism (VTE) care, announced today the US Food and Drug Administration has approved its Investigational Device Exemption (IDE) application to initiate the QUADRA-PE study (NCT06672510) evaluating the Katana™ Thrombectomy System in patients with acute pulmonary embolism (PE). The co-principal investigators of the pivotal study are Sanjum Sethi, MD, Interventional Cardiologist at Columbia University Medical Center, and Ann Gage, MD, Critical Care and Interventional Cardiologist at Tristar Centennial Medical Center. The Katana System consists of: The QUADRA-PE study is a multi-center, international trial designed to enroll up to 118 patients with clinically significant acute PE at up to 26 sites globally. The primary effectiveness endpoint is the reduction in right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure as assessed by CT angiography. The primary safety endpoint is the composite…


